1. I

    "We don't have enough resources" as an Audit Non-conformance Response

    I was taught during my ISO training that a response from an auditee that "we don't have the resources" to complete a quality related is in itself a non-conformance related to Resourcing and Planning for the QMS. Any input on this?
  2. Marc

    Free "Cove Members" Files Directory 1.0

    Free to All Forum Visitors! The Elsmar Cove Free "Members" Files Directory. There are a lot of files in this directory, but BEWARE. Some are several years old or older. Use a file with care. Make sure it is appropriate for your use. Many of these files have been donated to the site from one...
  3. Marc

    Free The Old "pdf_files" Directory 1.0

    Free to All Forum Visitors! The Elsmar Cove Free Files Directory. There are a lot of files here, but BEWARE. Some are several years old or older. Use a file with care. Make sure it is appropriate for your use. Many of these files have been dontated to the site from one person or another over...
  4. wsparrow

    Is sharing resources treated same way as remote function?

    Hello everyone, We have multiple manufacturing facilities around the area with headquarters identified as remote site for all (provide design and some other support functions to all facilities). Some of the facilities are certified to new IATF-16949 standard and some currently going through...
  5. J

    Suggestions on Inadequate Resources in a Small Machine Shop

    I work in a 35 person machine shop who is currently certified to AS9100C. During our last audit we had a number of NCR's issued. My top management relies on mostly me (Quality Mgr/Magmt rep) to take care of ALL activities related to being certified. I submitted on a couple of them that the...
  6. J

    IATF 16949 - 3 Year Calendar Period for Audits

    Due to a lack of resources, I am thinking of changing from an annual audit plan to a 3-year plan based on the new IATF 16949 verbiage. Specifically, & for QMS and Process Audits. Despite how I bet the outside auditors would look at this, has anyone else changed from an annual...
  7. A

    Difference between requirement for 4.4.1a (inputs) and 4.4.1d (resources needed)?

    What is the difference between requirement for 4.4.1a (inputs) and 4.4.1d (resources needed)? As I see in ISO 9002:2016 inputs can be materials, equipment etc., and resources are, among others, monitoring and measuring resources (also equipment). So, 4.4.1d includes 4.4.1a (inputs)??
  8. N

    ISO9001:2015 clause 7.1.5 "Resources" (Formerly "Equipment")

    I think I'm getting caught up in the word "resources" - for this clause, we need to ensure that we have equipment that is suitable and maintained, but when I see the word resources I think people... am I reading to much into this? I have been looking at this standard all day:bonk: Thanks Covers!
  9. J

    Auditor says 5.6.3 should be discussed in Management Review

    Being audited today, the auditor says 5.6.3 Resource Needs, should be discussed... Isn't that an output? No one noted any resource needs so there was no decision ... Who's right? This is from the auditors NCR Requirement: Clause 5.6.3 of the ISO/TS 16949:2009 Standard states that the output...
  10. L

    Evaluation of Required Resources for Internal Audits

    Hello I just planned the audit schedule for 2013 and of course, I'm using personel from other departments to audit (audit team, as my own quality dpt. is understaffed). Put in cc: the bosses of the internal auditors in the 2013 planning, one replied by asking how much time it should take in...
  11. U

    PROBLEM: Probability of Resource Access Collision

    Greetings! I would like to ask for assistance with this problem: A set of units access a system resource at random intervals. I'd like to compute the probability (the "likelihood") that a given unit would attempt to access the resource at the same time as another (a "collision"). Having...
  12. L

    Formal Resource Request Form example wanted

    Hello, Resources in my Quality Department have always been low. Sorry to say that but quality culture is lacking, president preaches for the "minimum" and we're affliged by "parilysis by analysis".:applause::sarcasm: Everybody recognizes in my organization the need for more presence from...
  13. S

    AS9100C Clause 6.1 Provision of Resources - New employees as Preventive Actions

    Hello, I am new to quality and an inexperienced internal auditor. It occurred to me that I could use Preventive Actions wherein we hired a production manager as well as a receiving manager. Can I use these PARS to satisfy the clause 6.1 demonstrating management's commitment to providing...
  14. I

    Cost to prepare 510(k) submission (resources, time, dollars)

    What has it cost you in time, resources, and dollars to prepare an abbreviated or special 510(k) submission. We have a Class II syringe applicator where we would like to change the manufacturer and the shape of the applicator. Thanks for any input.
  15. R

    Do we need to hire more people?

    I was reading a recent posting to a thread asking people to comment on how many QA people are in other organizations...."Number of Quality Personnel - How many quality personnel does your company employ?" by Toefuzz :applause: My question comes from a different perspective... Sometimes when I...
  16. S

    Inputs vs. Resources in the context of a Process - Differences

    A process is defined as "An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process." It means any process essentially consumes resources in order to transform inputs into outputs. What's...
  17. M

    Internal Audit questions on Technical Resources & Work Environment

    Hi there I am doing an internal audit on Technical Resources and Work Environment. Having trouble thinking of questions to ask. There is not alot in the standard about this. Not too sure where to start, Please help direct me in the right direction....Any suggestions would be greatly...
  18. D

    ISO 9001 - Responsibilities of Top Management in ensuring availability of resources

    Dear all, How can top management ensure availability of resources? Many thanks
  19. J

    Processes Interaction: Criteria and Methods

    Greetings! In continuation to our preparation for ISO 9001:2008 certification, we are now on identifying the different processes involved in our QMS and its interaction. As requirement in clause 4.1c, we determine criteria and methods, etc. to measure and achieve this processes...But since it...
  20. T

    Simple Layered Process Audit format - What are you using? Required resources & time?

    Hey gang, Here's my chance to ask for some help and input. . . What formats are you using to perform layered process audits? What overhead (resources) is required?? Approx. time of audit? I am interested primarily in maufacturing process audits. I know I'll get alot of great help here!
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